Authority in empirical bioethics

Prof. Stacy Carter1, Prof. Vikki Entwistle2, Prof.  Jackie Leach-Scully3

1Research for Social Change, University of Wollongong, The University Of Wollongong, Australia, 2Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, 3Policy Ethics and Life Sciences Research Centre, School of Geography, Politics and Sociology, Newcastle University, United Kingdom

A dominant problematic for empirical bioethics is the implied relationship between is and ought. At the heart of this problematic are questions about authority in research, which have been relatively neglected. In this paper, we report on work in progress investigating the forms of authority that are assumed or invoked in empirical bioethics projects. We will begin by contrasting several methodologies that are used for empirical bioethics. We then propose three forms of authority that may be assumed or invoked in research practices, and show that these forms of authority are assumed or invoked differently in different methodological traditions. We conclude by connecting our argument about authority to the is-ought tension, and considering how our thinking regarding authority might be reflected in research and reporting practices.


Biography:

Stacy Carter is Professor and Founding Director of Research for Social Change, a unit for values-based social science research in the Faculty of Social Science at the University of Wollongong.

Vikki Entwistle is Professor and Director of the Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore.

Jackie Leach-Scully is Professor and Executive Director of the Centre for Policy, Ethics and the Life Sciences in the School of Geography, Politics and Sociology at Newcastle University in the UK.

Contesting certainties and changing paradigms for young professionals: Establishing medical ethics curricula in Pakistan

Dr Sarosh Saleem1, Dr Fajar Raza2

1Shalamar Medical & Dental College, Lahore, Pakistan, 2Shalamar Medical & Dental College, Lahore, Pakistan

The pressing need for familiarity with the ethical dimensions of health care is acknowledged worldwide. United Nations Educational, Scientific and Cultural Organization (UNESCO) made ethics of science and technology, one of its five priority areas. In Pakistan, medical ethics education is still in its infancy but a few efforts are pushing towards a slow but positive change in paradigms. While ethics was previously taught passively, through doctor-patient observation, a few training programs in Ethics (mostly non-diploma) have been introduced for clinicians and researchers. Over the past decade, research ethics committees have also been established in many healthcare institutes. However, these programs have not kept pace with the growing need of bioethics training in Pakistan. Pakistan Medical and Dental Council is the authority on undergraduate medical curriculum. It has advised that Bioethics be taught to medical students but has not made it a mandatory subject. Hence, there still remains a dearth of trained professionals and organized trainings, particularly for undergraduate students.

Pakistan has a unique social, political and cultural context and interpreting and implementing core ethical values within this local context, is a big challenge. It is imperative that the curricula and protocols be tailored according to the local sociocultural milieu. Recently, a Bioethics Department has been established at Shalamar Medical and Dental College, Lahore-Pakistan. This is the only department in Pakistan that has adapted the core curriculum of UNESCO International Network of Bioethics, for undergraduate training of nursing and medical students. Our goal is to develop graduates who are not just clinically sound, but are compassionate, morally and culturally sensitive, and who will create an environment that enhances the experiences of the patients and their families. We hope that this initiative would serve as the first step of a long journey towards creating leaders in the field of ethical professionalism.


Biographies:

Dr. Sarosh Saleem is a physician trained in Pediatrics and Bioethics. She is the founding Head of Bioethics Department at Shalamar Medical & Dental College, Lahore Pakistan. This is the only department in Pakistan dedicated to undergraduate and postgraduate training of clinicians. Dr. Saleem did Masters in Bioethics (with distinction) from The Aga Khan University, Karachi-Pakistan in 2010. While working as a Specialist and Incharge of Pediatric Emergency Department, Dr. Saleem established a Hospital Ethics Committee at The Indus Hospital, Karachi-Pakistan. Later she successfully completed a Fellowship in Pediatric Bioethics from Children’s Mercy Hospital, Kansas City, MO-USA in 2017. She returned to Pakistan to establish the field of Bioethics in healthcare sector in Pakistan. Her areas of interest are End of life decision-making, socio-cultural and spiritual influences on clinical decision-making, moral distress and research ethics in developing countries. Dr. Saleem has attended and presented at many national and international forums, including Pediatric Academic Societies Conference (2016 SF-USA), American Society of Bioethics and Humanities (2016-KC, MO-USA), Medicine and Religion Conference 2016 (TX-USA). She has successfully conducted several workshops and conferences of Bioethics with participation from international speakers, in Pakistan.

Dr.Fajar Raza graduated from Aga Khan University, Karachi in 2016. She is currently working as a teaching assistant in the Department of Medical Education at Shalamar Medical and Dental College (SMDC), Lahore.She also has an avid interest in medical ethics education and is a member of the Bioethics Unit Committee at SMDC. As part of the Department of Medical Education, she has been collaborating with the Bioethics Department at SMDC to develop training sessions for healthcare professionals.

Should we offer resuscitation to babies born at 22 weeks?

Dr John Lantos1

1Childeren’s Mercy Hospital, Kansas City, Mo, United States

Survival rates for babies born at 22 and 23 weeks are steadily improving at centers that offer active treatment to these babies. For example, survival rates for these babies are about 30% in Japan, Sweden, Iowa, and Cologne. At these centers, survivors have outcomes that were similar to outcomes for babies born at 23 and 24 weeks of gestation.  Most survivors have no serious neurodevelopmental impairment (NDI) Nevertheless, many centers do not offer active treatment to babies at this gestational age.   One might expect these results to generate excitement, emulation, and replication.  Instead, the results are misrepresented by professional societies.  For example, One might expect that such a startling medical breakthrough would stimulate excitement, admiration, emulation, and research.  Oddly, it seems to have generated none of those things.  Instead, key professional societies have either ignored or misrepresented the outcome data.  For example, a 2016 statement by the American College of Obstetrics and Gynecology (ACOG) and the Society for Maternal and Fetal Medicine (SMFM)  wrote that “delivery before 23 weeks of gestation typically results in neonatal death (5–6% survival) and among rare survivors, significant morbidity is universal (98–100%).”  In this paper, I speculate about three reasons why many centers seem loath to offer a treatment that could save thousands of lives.  First, people overestimate both mortality rates and the rates of NDI among survivors, based on experiences in which such babies received inadequate treatment.  Second, successful treatment of extremely premature babies requires an institutional commitment and cooperation between maternal-fetal medicine and neonatology.  Finally, some people worry that survival of such tiny babies might lead to tighter restrictions on legal abortion at the end of the second trimester.   In conclusion, I will recommend careful study of outcomes using best practices for both shared-decision making and neonatal intensive care.


Biography:

John Lantos, MD, is Professor of Pediatrics at University of Missouri in Kansas City and the founding director of the Children’s Mercy Hospital Bioethics Center.  Prior to moving to Kansas City, he was a Professor of Pediatrics, Chief of General Pediatrics, and Associate Director of the MacLean Center at The University of Chicago. He has served President the American Society of Bioethics and Humanities as well as of the American Society of Law, Medicine, and Ethics.

From Kansas City, he directs an innovative, on-line program that is training a new generation of scholars from around the world in pediatric bioethics.

An ethical framework for antenatal counselling at the threshold of viability

Dr Andrew Hutchinson1

1Grantley Stable Neonatal Unit, Royal Brisbane and Women’s Hospital, Herston, Australia, 2University of Queensland, Faculty of Medicine, Herston, Australia, 3Department of Paediatrics, Mackay Base Hospital, Mackay, Australia

Extreme prematurity presents a number of challenges for health systems, clinicians and families. While advances in neonatal and perinatal medicine have increased the survival of babies who are born below 26 weeks gestational age, substantial morbidity remains prevalent in this population. In Australia, there is general consensus that the threshold of viability for premature infants exists between 23 weeks and 26 weeks gestational age. Life sustaining interventions for babies who are born prematurely are generally not recommended below 23 weeks gestational age and universally recommended above 26 weeks gestational age. At the threshold of viability, health professionals counsel parents and facilitate informed decision-making prior to delivery regarding the provision of life sustaining interventions or palliative care. Counselling involves a family-centred approach that explores parental values alongside education about prematurity and the risks of morbidity, disability and death. International studies suggest that there is widespread variation in antenatal counselling practices and that parental involvement in the decision-making process is inconsistent. Improving outcome data for survival, morbidity and disability dominates discussion in the academic literature around determination of the best interests of periviable infants and moral obligations to initiate life-sustaining interventions. This paradigm influences the dynamics of antenatal counselling and challenges the moral and legal role of parents in determining best interests and reaching informed decisions. A literature review has identified key social and ethical considerations for antenatal counselling at the threshold of viability that support the formulation of an ethical framework guided by principlism and discourse ethics. Fundamental principles include beneficence, respect for autonomy, partnership and trust. An ethical framework will provide a foundation for clinician counselling practices that supports collaborative, informed decision making at the threshold of viability in the best interests of infants and their families.


Biography:

Andrew Hutchinson is an advanced trainee in general paediatrics and neonatal / perinatal medicine with the Royal Australasian College of Physicians. He is completing a masters of public health and health management through the University of New South Wales involving the study of ethics and law in public health. He has a special interest in antenatal counselling for extreme prematurity including the dynamics of communication with parents.

What are the responsibilities of AABHL in relation to Australia’s policy on asylum seeker detention?

A/Prof. Deborah Zion1, A/Prof. Paul Macneill2, A/Prof. Chris Jordens2, Prof. Angus Dawson2

1Victoria University, Melbourne, Australia, 2University of Sydney, Sydney, Australia

Seeking asylum is protected by internationally agreed legal conventions, to which Australia is a signatory. Those seeking asylum are often fleeing violence, conflict or other serious threats to well-being. In 1992 the Australian government introduced a system of mandatory detention for asylum seekers while their claims for refugee status are assessed. More recently, asylum seekers who arrive by boat have been singled out for especially harsh treatment, detained off-shore in two locations: Manus (Papua New Guinea) and Nauru. The conditions in these camps, which include high levels of self-harm, riots and preventable deaths due to inadequate medical treatment, aim explicitly to deter other potential Asylum Seekers from attempting to come to Australia. The treatment of detainees has been held to be a clear abuse of basic human rights by a number of national and international investigations.

AABHL is a regional bioethics organisation with a large Australian membership. To our knowledge AABHL has remained silent in response to this situation (despite this issue being raised by Macneill (2003) with a prior Australasian bioethics body). We will use the case of Australian asylum seeker policy to raise a series of questions about the responsibility of AABHL as an organisation.

In this workshop, through a guided discussion of all participants in the workshop, we will seek to:

  • Argue that AABHL as an organisation has a responsibility to do something on this issue
  • Explore what action might be appropriate
  • Explore possible counter-arguments to taking action (e.g. people have different views, individuals can act but an organisation should be neutral, given the injustices in the world where do we stop, AABHL does not just have Australian membership etc.) and suggest why they do not outweigh the proposed responsibility.

Biographies:

Deborah Zion is A/Prof. at Victoria University. She has focused much of her recent research on ethical and legal issues related to asylum seekers in Australia.

Paul Macneill is A/Prof. at Sydney Health Ethics. He wrote a paper published in 2003 in the journal ‘Bioethics’ calling for bioethics organisations to act in response to Australia’s asylum seeker policies.

Chris Jordens is A/Prof. at Sydney Health Ethics. His research has covered a broad spectrum of issues in bioethics but has always focused on philosophy, politics and language.

Angus is Professor of Bioethics and Director of Sydney Health Ethics. His main research interests are public health ethics, research ethics and global ethics.

Case study: Dr Bawa-Gaba – guilty of manslaughter by gross negligence

Janine Mcilwraith1, Jacob Sutton1

1Slater & Gordon Lawyers, Melbourne, Australia

This paper will examine the UK case of a junior doctor whom, as a result of her clinical care of a young boy, was found guilty of manslaughter by gross negligence. This talk will look at the facts of the case and the media attention it received and pose the question whether criminal prosecution of individual doctors in a setting of multiple system failures is ethical and just. It will also examine criminal prosecutions of doctors in Australia to date in an attempt to draw conclusions as to whether a similar situation could arise here.


Biographies:

Janine is a health lawyer who works as a Principal Lawyer with Slater & Gordon, in their Medical Law Department. She has co-authored two prominent medical law texts, Health Care and the Law (4th, 5th & 6th editions) and Australian Medical Liability (1st & 2nd editions). In addition Janine co-authored the National Disability Insurance Scheme Handbook and has written and edited a number of chapters for Halsbury’s Laws of Australia focusing on professional negligence and professional registration in the health arena and is also the author of the chapter on surrogacy. Janine is the general editor for Australian Civil Liability Bulletin. Janine co-taught Medical Law and Public Health Law at University of Western Sydney in 2014. In 2016 Janine took on the role of Sessional Senior Fellow at Monash University teaching Health Law to Masters and JD students. Janine is also Adjunct Associate Professor in the Faculty of Law at University of New England.

Jacob Sutton is a solicitor who has practiced exclusively in Medical Law at Slater and Gordon Lawyers since 2016. He has acted in litigated matters concerning all areas of healthcare, including delays in diagnosis and diagnosis errors (particularly relating to cancer), surgical misadventure, obstetrics and injuries sustained during treatment from allied health professionals.

A defence of risk relative capacity

Sam Boyle1

1School Of Law, Queensland University Of Technology, Brisbane, Australia

Risk relative capacity, the idea that riskier decisions require a higher level of capacity than less risky decisions, is controversial. Significantly, it creates the possibility that a person could have capacity to accept medical treatment, but not to refuse it. However, although risk relative capacity does carry the danger of equating incapacity with treatment refusal, a danger that must be managed, I defend its place in the law of capacity.

Firstly, there is no clear line between capacity and incapacity; legal capacity is a political, legal judgment. While the risk of a decision should never be considered determinative of capacity, it is a legitimate factor that may be taken into account. A number of writers have rejected risk relative capacity, but endorsed giving more scrutiny to capacity in cases of high risk. I argue that this amounts to the same thing, and the justification for more scrutiny of capacity in cases of high risk is the same as that for risk relative capacity.

Secondly, I argue that not testing capacity in cases of low risk decisions is a form of risk relative capacity, and that this practice is a sensible way of determining when capacity should be assessed.

Finally, I argue that if it is used properly, risk relative capacity can actually be a tool for patient empowerment. This is because it ought to challenge doctors to demonstrate the risk of refusing treatment. Moreover, ‘risk’ in medical treatment decisions is not one-directional. There is also a risk involved in the removal of a person’s capacity, and in the provision of unwanted medical treatment. Therefore, risk relative capacity could actually make it more likely for someone refusing treatment to be found to have capacity.


Biography:

Sam is a lecturer at Queensland University of Technology. He teaches property law, medical law and administrative law. Sam is completing a PhD on the issue of capacity in the case of anorexia nervosa at University of Queensland.

The ethics of farming human-pig chimeras and non-chimeric pigs

Dr Koplin Julian1

1University Of Melbourne, Carlton, Australia

It may soon be possible to generate human organs inside of human-pig chimeras (animals composed of a mix of pig and human cells) via a process called interspecies blastocyst complementation. This paper discusses the central ethical concern raised by this practice, which I term the moral uncertainty argument. The moral uncertainty argument holds that human-pig chimeras may possess cognitive capacities that are morally relevant but difficult to detect. Accordingly, if we kill human-pig chimeras for their organs, we risk perpetrating a serious moral wrong.

After describing the moral uncertainty argument against ‘farming’ human-pig chimeras, this paper shows how the same argument may apply to our current uses of non-chimeric pigs in agriculture and research – practices that are not widely considered ethically controversial. There is therefore an important tension between two common moral views: that farming human-pig chimeras for their organs is ethically concerning, and that farming non-chimeric pigs for food or research is ethically benign. In the interests of moral consistency, at least one of these views ought to be revised.


Biography:

Julian Koplin is a Research Fellow with the Biomedical Ethics Research Group, Murdoch Children’s Research Institute and Melbourne Law School, the University of Melbourne. His research interests include the ethics of emerging biotechnologies, the methods of philosophical bioethics, and transplant ethics. Julian was awarded his PhD in bioethics from Monash University in 2017.

Ethics in personalised medicine research: Case study of an iPSC-based system for predicting individual treatment responses

Dr Mary Jean Walker1

1Monash University, Clayton, Australia, 2ARC Centre of Excellence for Electromaterials Science, Wollongong, Australia

Progress has recently been made into developing tissue cultures grown from induced pluripotent stem cells (iPSCs) suitable for testing how particular patients will respond to treatments. These would be of use in developing treatment regimens for conditions where multiple treatment options exist, but we lack definitive ways of telling which treatment will work best for which patient (e.g., schizophrenia, epilepsy). An iPSC tissue culture system could prevent patients from having to undergo sometimes significant periods of trialling various treatments before finding one that works for them. They could also provide data for individualising dosages.

Using iPSC cultures in this way is, we have argued elsewhere, a novel method of gaining knowledge for clinical practice, as it does not rely on the two traditional sources of evidence for predicting individual treatment responses (evidence about mechanisms and population-level correlational studies). Its novelty brings with it a number of unknowns, which raise practical and ethical questions. For instance, It is not clear what level of predictive certainty should be expected before results can be taken to direct clinical practice, and what sorts of studies should be used to test this. Candidate conditions for the system may have complex and contested subtype nosologies, implying potential variations in system reliability across patients, indicating the need for care in thinking through which patients are candidates for the system. Further, such a system does not clearly fit into current regulatory schemes, and decisions about their regulatory treatment could influence researcher decisions.

In this paper, we map the issues arising from the currently unique status of this method of predicting patient responses to treatment, with a view to developing a framework of ethical considerations for researchers working in this area.


Biography:

Mary Jean Walker is a Research Fellow at Monash University in Melbourne. She has research interests in bioethics, philosophy of medicine, health policy, and personal and narrative identity. In her current role she is researching ethical issues related to advanced medical devices and personalised medicine.

The need for ethics committees and evaluation agencies in coverage with evidence development: The case of crizotinib in Australia

Dr Drew Carter1, Ms Arlene Vogan1, Prof Tracy Merlin1

1Adelaide Health Technology Assessment, The University of Adelaide, Adelaide, Australia

In 2013 Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) requested a 30% price reduction from the pharmaceutical industry sponsor of crizotinib, a treatment for anaplastic lymphoma kinase-positive non-small cell lung cancer.  PBAC requested the price reduction after judging that the sponsor had over-estimated the effectiveness of the treatment.  The sponsor refused to reduce the price, so in 2014 PBAC and the sponsor agreed on a coverage-with-evidence-development (CED) arrangement.  The sponsor would collect and analyse data on a sub-set of Australian patients being treated with government-subsidised crizotinib in order to determine the effectiveness and cost-effectiveness of the treatment. Following analysis of this data, PBAC would recommend ongoing government subsidy but only at a price that was supported by the data.

The CED arrangement was innovative and testified to the feasibility of government and industry collaborating on CED in Australia.  But it also featured some problems.  In particular, we examine the following ethical issues.  Were patients aware that they could opt out of the evidence development?  Was an opt-out consent process ethically justified to begin with?  Were patients induced into participating in the evidence development?  Was the presence of any inducement ethically justified?  Who ought to have been recruiting patients into the evidence development?

We show that formal ethical review would solve a number of problems faced by CED arrangements.  We also show how engaging an independent body with relevant expertise in technology evaluation would enhance the ethical acceptability of CED arrangements.


Biography:

Drew Carter is a moral philosopher and health policy researcher. He applies insights made by Ludwig Wittgenstein to illuminate bioethical issues, especially relating to resource allocation.  He has published on assisted reproductive technology and pain.  His current research focusses on intensive care triage and the managed entry of health technologies.

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About the Association

The Australasian Association of Bioethics and Health Law (AABHL) was formed in 2009.

It encourages open discussion and debate on a range of bioethical issues, providing a place where people can ask difficult questions about ideas and practices associated with health and illness, biomedical research and human values.

The AABHL seeks to foster a distinctive Australasian voice in bioethics, and provide opportunities for international engagement through its membership, journal and conferences.

Members come from all the contributing humanities, social science and science disciplines that make up contemporary bioethics.

Many members have cross-disciplinary interests and all seek to broaden the dialogues in which all members of the wider community ultimately have an interest.

The AABHL is a supportive, creative and challenging community that provides a rich source of continuing academic refreshment and renewal.

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